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Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

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ClinicalTrials.gov Identifier: NCT00516152
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : January 26, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Study Description
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Brief Summary:
The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplasia Acute Lymphocytic Leukemia Severe Aplastic Anemia Non-Hodgkin's Lymphoma Lymphoproliferative Disease Multiple Myeloma Advanced Myeloproliferative Disease Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
Study Start Date : November 2002
Actual Study Completion Date : November 2007

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Arms and Interventions
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Intervention Details:
  • Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF

    Day Preparative Regimen for GVHD Prophylaxis

    • 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
    • 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
    • 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
    • 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
    • 3 Fludarabine 30 mg/m(2)IV
    • 2 REST Tacrolimus 0.01 mg/kg CIVI

    • 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion

      • 1 Methotrexate 5mg/m(2)IV
      • 3 Methotrexate 5mg/m(2)IV
      • 6 Methotrexate 5mg/m(2)IV
      • 7 G-CSF 5mcg/kg SQ daily
      • 11 Methotrexate 5mg/m(2)IV
      • 90 Evaluate Response

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years to 61 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No fully or single-antigen mismatched sibling donor is available to donate stem cells.
  • Age >15 and <61
  • ECOG PS < or equal to 2
  • Adequate renal function with serum creatinine <2.0 mg/dl
  • Pulmonary diffusing capacity >40% of predicted
  • Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
  • No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
  • Negative serology for the human immunodeficiency virus (HIV)
  • Available HLA-matched donor (see HLA compatibility requirements below)
  • Signed informed consent from the recipient

Exclusion Criteria:

  • Ongoing active infection
  • Pregnancy and/or nursing
  • Active, uncontrolled CNS leukemia
  • Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
  • Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516152


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
More Information
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Additional Information:

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Responsible Party: Beth Davis, University of California San Francisco
ClinicalTrials.gov Identifier: NCT00516152    
Other Study ID Numbers: UC-2214
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009
Keywords provided by University of California, San Francisco:
Matched Unrelated Donor
Stem Cell Transplantation
Busulfan
fludarabine
Hematopoietic Disorder
Additional relevant MeSH terms:
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Leukemia
Multiple Myeloma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anemia, Aplastic
Myeloproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, Lymphoid
Leukemia, Myeloid
Bone Marrow Diseases
Anemia
Methotrexate
Fludarabine phosphate
Fludarabine
Busulfan
Tacrolimus